In-process specs & reconciliation (21 CFR 111.110)

21 CFR 111.110 requires written in-process specifications for any point/step/stage of manufacturing where control is needed to ensure the quality of the supplement, with material reconciliation at each. The typical points: blend uniformity, capsule/tablet weight, hardness, friability, disintegration, in-process moisture, fill weight. The reconciliation (theoretical vs actual yield, with investigation of any excursion outside the action limit) is checked at every FDA inspection.